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Regeneron Aims To Enter Lucrative Diabetic Blindness Market One Year Early

Roche sells Lucentis, a treatment for diseases that cause age-related blindness. The drug generates $1.6 billion in global annual sales. But sales of the once fast-growing product ticked down 3% last year largely because of an upstart: Eylea, a similar drug from Regeneron Pharmaceuticals that can be injected into the eye less often. In 2012, its first full-year on the market, Eylea generated $850 million in annual sales, partly at Lucentis’ expense.

One thing that has helped Lucentis compete is that it is approved for a use that Eylea is not: treating loss of vision due to diabetes, known as diabetic macular edema (DME). On its most recent earnings conference call, Daniel O’Day, the chief operating officer for Roche’s pharmaceutical division, said that he did not expect Eylea to impact the DME market “for a couple of years” and predicted that the “uptake penetration of Lucentis in DME” would continue “for the foreseeable future.”

This morning, Regeneron announced that it would be filing a new drug application to market Eylea for treating DME this year, a year ahead of schedule. “Concerted discussions with the FDA led us to make that change,” says Leonard Schleifer, Regeneron’s founder and chief executive officer. Previously, Regeneron had thought that it needed to collect two years of data from each of its clinical trials before filing.

The company also announced one-year data from two clinical trials testing Eylea in DME. In both, patients were randomly assigned to either receive two milligrams of Eylea monthly, two mg. of Eylea once every other month, or a laser surgery. In the first study, patients who got Eylea monthly were able to read an extra 12.5 letters, about two lines, on an eye chart. Those who got Eylea every other month were able to read an extra 10.7 letters. And those who received the laser procedure could read an extra 0.2 letters.

The second study was similar: The once-a-month group were able to read 10.5 letters more than when they started, the every other month group 10.7 letters more, and the laser group 1.2 letters more. That could lead to a repeat of what happened in age-related macular degeneration, where less frequent dosing allowed Regeneron to compete effectively with Roche because of the expense of getting patients into the office more often and monitoring them when they were there.

Regeneron could have another advantage, too, depending on what its safety data look like. Lucentis carries a warning : “Fatal events occurred more frequently in DME patients treated monthly with Lucentis compared with control.” In its press release, Regeneron says only that blood-clotting related adverse events and other serious adverse events occurred at similar rates among those who got Eylea and those who didn’t.

But the company needs the DME indication. Sales of Eylea came in just under analyst expectations. According to Jefferies analyst Biren Amin, who is neutral on the stock, U.S. sales of Eylea came in at $330 million, half a million below analyst consensus. In pre-market trading, shares fell 3.6% to $261.

Outside the U.S., Eylea is sold by Regeneron’s partner, BayerBayer Healthcare. Regeneron will present the data to investors as part of its previously announced earnings call today at 8:30.

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